Clobetasol Propionate Ophthalmic Nanoemulsion, 0.05% in the Treatment of Inflammation After Cataract Surgery in Pediatric Population

A Phase 3, Multicenter, Randomized, Evaluator-blinded Clinical Trial to Assess the Safety and Efficacy of Clobetasol Propionate Ophthalmic Nanoemulsion, 0.05% Compared to Prednisolone Acetate, 1% in the Treatment of Inflammation After Cataract Surgery in Pediatric Population 0 to 3 Years of Age (CLOSE-3)

Clobetasol Propionate Ophthalmic Nanoemulsion, 0.05% in the Treatment of Inflammation After Cataract Surgery in Pediatric Population (NCT05724446) is a Phase 3 interventional studying Cataracts Infantile, sponsored by Salvat. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

Multicenter, randomized, evaluator-blinded clinical trial compared to Prednisolone acetate, 1% in the treatment of inflammation and pain after cataract surgery in pediatric population. This study will assess the safety of Clobetasol propionate ophthalmic nanoemulsion, 0.05% to that of Prednisolone acetate, 1% when administering one drop four times a day (QID) for 14 days followed by a tapering period of 14 days after cataract surgery.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Cataracts Infantile, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 60 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Cataracts Infantile subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Male or female, aged 0 to 3 years old (have not had their 4th birthday) on the day of consent. - Patients who are candidate for routine, uncomplicated cataract surgery in one eye with or without intraocular lens. - Patients whose caregiver(s) is/are able and willing to comply with all treatment and follow-up procedures. - Signed willing to sign a consent form from (ICF) parents or patient's legally authorized representative(s). - Patients who have undergone routine, uncomplicated cataract surgery in one eye with or without intraocular lens. - Patients with clinical evidence of postoperative inflammation (anterior chamber inflammation grade \> 0). Who Should NOT Join This Trial: - Presence of any active or suspected viral, bacterial, or fungal disease in the study eye. - Active uveitis in the study eye. - Ocular neoplasia in the study eye. - Post-traumatic cataract in the study eye. - Suspected permanent low vision or blindness in the fellow non-study eye. The study eye must not be the patient's only good eye. - Use of any topical medication in the study eye within 2 days prior to surgery, except for those required for ocular examination or preoperative preparation. - Systemic administration of any steroidal anti inflammatory drugs in the previous 2 weeks prior to the surgery. - Systemic administration of any non-steroidal anti inflammatory drugs in the previous 48 hours prior to the surgery. - Patient or patient's breastfeeding mother who is expected to use corticosteroids (except corticosteroid inhalers and dermatological corticosteroids, as long as they are not used on the eyelids or surrounding area, and oral prednisolone steaglate drops as part of the standard treatment after cataract surgery) or immunosuppressants during the 30 days following cataract surgery. - History of steroid-induced increase in IOP in either eye. - Patients with glaucoma, ocular hypertension, or those receiving IOP lowering therapy in either eye or systemically. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Male or female, aged 0 to 3 years old (have not had their 4th birthday) on the day of consent. * Patients who are candidate for routine, uncomplicated cataract surgery in one eye with or without intraocular lens. * Patients whose caregiver(s) is/are able and willing to comply with all treatment and follow-up procedures. * Signed informed consent from (ICF) parents or patient's legally authorized representative(s). * Patients who have undergone routine, uncomplicated cataract surgery in one eye with or without intraocular lens. * Patients with clinical evidence of postoperative inflammation (anterior chamber inflammation grade \> 0). Exclusion Criteria: * Presence of any active or suspected viral, bacterial, or fungal disease in the study eye. * Active uveitis in the study eye. * Ocular neoplasia in the study eye. * Post-traumatic cataract in the study eye. * Suspected permanent low vision or blindness in the fellow non-study eye. The study eye must not be the patient's only good eye. * Use of any topical medication in the study eye within 2 days prior to surgery, except for those required for ocular examination or preoperative preparation. * Systemic administration of any steroidal anti inflammatory drugs in the previous 2 weeks prior to the surgery. * Systemic administration of any non-steroidal anti inflammatory drugs in the previous 48 hours prior to the surgery. * Patient or patient's breastfeeding mother who is expected to use corticosteroids (except corticosteroid inhalers and dermatological corticosteroids, as long as they are not used on the eyelids or surrounding area, and oral prednisolone steaglate drops as part of the standard treatment after cataract surgery) or immunosuppressants during the 30 days following cataract surgery. * History of steroid-induced increase in IOP in either eye. * Patients with glaucoma, ocular hypertension, or those receiving IOP lowering therapy in either eye or systemically. * Any current corneal abrasion or ulceration. * Known or suspected allergy or hypersensitivity to similar drugs, such as other corticosteroids, or their components. * Patients who have had ocular surgery in the study eye within 90 days prior to surgery. * History of post-operative unresolved inflammation in the contralateral eye. * Presence or history of chronic generalized systemic disease that the Investigator believes may either increase the risk to the subject or confound the results of the study (e.g., Diabetes mellitus, human immunodeficiency virus \[HIV\], acquired immunodeficiency syndrome \[AIDS\]). * Any concurrent process which, in the opinion of the investigator, could impair patients' safety or limit adherence to the study protocol. * Participation in any study of an investigational topical or systemic new drug or device within 30 days prior to screening, or at any time during the study. * Prior participation in the study described in this protocol unless the patient wasn't randomized.

Treatments Being Tested

DRUG

Clobetasol Propionate

Clobetasol propionate ophthalmic nanoemulsion 0.05 % is an oil-in-water (O/W), clear or slightly yellowish nanoemulsion containing the active ingredient clobetasol propionate at a concentration of 0.05% weight per weight (w/w).

DRUG

Prednisolone acetate ophthalmic suspension, 1%

Microfine sterile ophthalmic suspension of dense and whitish appearance.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Hospìtal Sant Joan de Deu

Barcelona, Spain

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05724446), the sponsor (Salvat), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05724446 clinical trial studying?

Who can participate in NCT05724446?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05724446?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05724446. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05724446. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.